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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K964531
Device Name PROFILE 70000 QUADRATURE VOLUME NECK COIL
Applicant
US ASIA INSTRUMENTS, INC.
675-B ALPHA DR.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact RONY THOMAS
Correspondent
US ASIA INSTRUMENTS, INC.
675-B ALPHA DR.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact RONY THOMAS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/12/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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